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E-Folder - Seven Reasons Why You Need A Strategic Planning Facilitator
A professional facilitator brings an independent and open-minded perspective to your strategic planning process. He or she will keep the
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
discussion focused, keep the process on track, and will encourage team members to act as equals in the process. Some organizations choose
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
to “go it alone” and attempt to conduct the strategic planning process entirely “in house.” In my own personal and professional experien
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
es over more than 35 years, I have always witnessed better outcomes of the strategic planning process when an outside professional facilit
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ator is brought in. In fact, many of my clients come to me AFTER they have tried and failed at doing the process themselves.
Okay, so wh
Okay, so wh
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
n and why should you use a strategic planning facilitator? Your strategic thinking business coach offers the following advice to answer t
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
hat question. Here are seven reasons why it is recommended that you hire an outside facilitator.
1. If you want to ensure a level playi
1. If you want to ensure a level playi
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
ng field between the CEO and the team members. The outside facilitator has the skills to make sure the CEO does not take over and run the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
meeting.
2. If you want to increase the probability of a successful outcome. The facilitator has the experience of going through many o
2. If you want to increase the probability of a successful outcome. The facilitator has the experience of going through many o
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
f these and brings that experience to bear for your benefit.
3. If you want to complete the process in a timely manner. The facilitator
3. If you want to complete the process in a timely manner. The facilitator
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
will commit to making sure you finish the process in the time allotted to do so.
4. When you want to participate yourself. It is extrem
4. When you want to participate yourself. It is extrem
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ely difficult, if not possible,
for the CEO or other inside person to effectively facilitate because the other people will still react t
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
o the CEO or inside person as their superior.
5. When you need to address sensitive issues and conflicts. An outsider brings the benefi
5. When you need to address sensitive issues and conflicts. An outsider brings the benefi
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
of a dispassionate perspective and can more effectively diffuse arguments and channel intense moments into problem solving moments.
6.
6.
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
When your team is not making any progress. The outside facilitator will raise issues that you may try to avoid and will point out the dys
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
unctional behaviors that are being denied.
7. When your group must address complex issues and diverging viewpoints. The experience of t
7. When your group must address complex issues and diverging viewpoints. The experience of t
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
he facilitator will help identify the issues, generate options to resolve issues, and make decisions.
If you would like to learn more abo
If you would like to learn more abo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ut the importance of using an outside professional facilitator for your strategic planning efforts and how a strategic thinking business c
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ach can serve as your guide and facilitator in that process, please contact Glenn Ebersole through his website at elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
nesscoach4u.com/" TARGET="_blank">http://www.businesscoach4u.com/ or by email at jgecoach@aol.com
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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